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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02649946




Registration number
NCT02649946
Ethics application status
Date submitted
4/01/2016
Date registered
8/01/2016
Date last updated
21/12/2021

Titles & IDs
Public title
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
Scientific title
A Prospective, Multi-Center, Randomized, Concurrently-Controlled Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW)
Secondary ID [1] 0 0
BPV-14-005
Universal Trial Number (UTN)
Trial acronym
AVeNEW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stenosis 0 0
Restenosis 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Covera Vascular Covered Stent following PTA
Treatment: Surgery - Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon

Experimental: Covera Vascular Covered Stent following PTA - Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Active comparator: PTA only using uncoated PTA Balloon - Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.


Treatment: Devices: Covera Vascular Covered Stent following PTA
Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Treatment: Surgery: Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
Treatment of stenoses with PTA only
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
Timepoint [1] 0 0
6 months post index procedure
Primary outcome [2] 0 0
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
Timepoint [2] 0 0
30 days post index procedure
Secondary outcome [1] 0 0
Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure
Timepoint [1] 0 0
12 months post-index procedure
Secondary outcome [2] 0 0
Number of Participants With Access Circuit Primary Patency (ACPP).
Timepoint [2] 0 0
6 months post index procedure
Secondary outcome [3] 0 0
Number of Participants With Target Lesion Primary Patency (TLPP)
Timepoint [3] 0 0
1, 3, 18 and 24 months post index procedure
Secondary outcome [4] 0 0
Number of Participants With Access Circuit Primary Patency (ACPP)
Timepoint [4] 0 0
1, 3, 12, 18, and 24 months post index procedure
Secondary outcome [5] 0 0
Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
Timepoint [5] 0 0
Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure
Secondary outcome [6] 0 0
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Timepoint [6] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [7] 0 0
Total Number of Target Lesion Reinterventions
Timepoint [7] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [8] 0 0
Index of Patency Function (IPF)
Timepoint [8] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [9] 0 0
Index of Patency Function - Target Lesion (IPF-T)
Timepoint [9] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [10] 0 0
Number of Participants With Post-intervention Secondary Patency
Timepoint [10] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [11] 0 0
Number of Participants With Technical Success
Timepoint [11] 0 0
On Day of Index Procedure
Secondary outcome [12] 0 0
Number of Participants With Procedure Success
Timepoint [12] 0 0
On Day of Index Procedure

Eligibility
Key inclusion criteria
Clinical

* Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
* Subject must be either a male or non-pregnant female = 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
* Subject must be willing to comply with the protocol requirements, including the clinical and telephone follow-up.
* Subject must have an upper extremity arteriovenous (AV) fistula that has undergone at least one successful dialysis session with two-needle cannulation, prior to the index procedure.

Angiographic

* Subject must have angiographic evidence of a stenosis = 50% (by visual estimation) located in the venous outflow of the AV access circuit and present with clinical or hemodynamic evidence of AV fistula dysfunction.
* The target lesion must be = 9cm in length. Note: multiple stenoses may exist within the target lesion.
* The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0 and 9.0mm.

Clinical
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The subject is dialyzing with an AV graft.
* The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
* The hemodialysis access is located in the lower extremity.
* The subject has an infected AV fistula or uncontrolled systemic infection.
* The subject has a known uncontrolled blood coagulation/bleeding disorder.
* The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
* The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
* The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
* The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

Angiographic

* Additional stenotic lesions (= 50%) in the venous outflow that are > 3cm from the edge of the target lesion and are not successfully treated (defined as < 30% residual stenosis) prior to treating the target lesion.
* An aneurysm or pseudoaneurysm is present within the target lesion.
* The location of the target lesion would require the COVERA™ Vascular Covered Stent be deployed across the elbow joint.
* The target lesion is located within a stent.
* The location of the target lesion would require that the COVERA™ Vascular Covered Stent be deployed at or across the segment of fistula utilized for dialysis needle puncture (i.e., "cannulation zone").
* The location of the target lesion would require that the COVERA™ Vascular Covered Stent be placed in the central veins (subclavian, brachiocephalic, superior vena cava (SVC)) or under the clavicle at the thoracic outlet.
* There is incomplete expansion of an appropriately sized angioplasty balloon to its expected profile, in the operator's judgment, during primary angioplasty at the target lesion prior to randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2021
Sample size
Target
Accrual to date
Final
280
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Kensington Gardens
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
5068 - Kensington Gardens
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Austria
State/province [13] 0 0
Graz
Country [14] 0 0
Belgium
State/province [14] 0 0
Vlaams-Brabant
Country [15] 0 0
Germany
State/province [15] 0 0
Würzburg
Country [16] 0 0
Netherlands
State/province [16] 0 0
Maastricht
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
Switzerland
State/province [18] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
Trial website
https://clinicaltrials.gov/study/NCT02649946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bart Dolmatch, M.D.
Address 0 0
The Palo Alto Medical Foundation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02649946